About Cathy Oliveri

Cathy Oliveri spent thirteen years at FDA, including eleven at the Center for Devices and Radiological Health. Her last role there was Assistant Director for Process Improvement, leading a team of 13 Lean Six Sigma practitioners and a separate team of Agile data scientists on center-wide projects spanning pre-market and post-market functions. Earlier FDA roles included CDRH’s Office of In Vitro Diagnostics, the FDA Office of the Commissioner, and CDRH’s Office of Compliance.

Oliveri Consulting was founded in January 2026 to work directly with medical device companies on quality and regulatory work, and with government and commercial organizations on Lean Six Sigma and process improvement.

Career History

FDA – Center for Devices and Radiological Health (2012 – 2025)

Eleven years at CDRH, with sixteen months at the FDA Office of the Commissioner.

As Assistant Director for Process Improvement, she led a 13-person team of Lean Six Sigma practitioners on center-wide DMAIC, Agile, and Design Thinking projects. She separately led a team of Agile data scientists who built center-wide compliance dashboards; that team was the only FDA software group certified to ISO 9001:2015. As a Certified Master Black Belt, she also facilitated the cross-functional team that reduced Early Alert time for potential Class I Recalls from 30 days to approximately 10 days. The work across these teams was recognized with three CDRH team awards in 2024.

Earlier CDRH roles included Assistant Director for Technology and Policy Application at the Office of In Vitro Diagnostics, overseeing evaluations of digital health technologies, data analytics, quality documentation, and process standardization across five divisions, and reviewing cardiac device Establishment Inspection Reports, recalls, and 30- and 180-day PMAs in the Office of Compliance.

Transportation Security Administration (2008 – 2012)

Built TSA Operations’ first LSS training program for the Office of Security Operations, growing it from $3M to $30M over three years across more than 130 airports.

Lockheed Martin Transportation and Security Solutions (LMTSS)

Senior Staff Systems Engineer and Certified Master Black Belt. Led Lean Six Sigma projects and served as CMMI Level 5 Lead, resulting in LMTSS’s first appraisal at the highest CMMI level. Trained over 300 Green Belts across more than ten certification courses and developed a data visualization module later adopted into Lockheed’s corporate LSS training curriculum.

Earlier Career

SAS Institute (1999–2001): Re-established the SAS Consulting Product Quality Management department and trained staff on CMMI, ISO 9001, and FDA GMP.

IBM Corporation (1985-1999): Multiple roles from Software Developer to Advisory Software Engineer and Architect. Led the first ISO 9000 certification for any IBM Image product development group.

Education

MS, Computer Science – Johns Hopkins University, Whiting School of Engineering (GPA: 4.0)

BA, Statistics – Princeton University

Certifications